CARDINAL HEALTH - Surgical Marking Pen Prep Resistant Regular Tip - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Surgical Marking Pen Prep Resistant Regular Tip Ruler and Labels

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More Product Details

Catalog Number

270PRL

Brand Name

CARDINAL HEALTH

Version/Model Number

270PRL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FZZ

Product Code Name

MARKER, SKIN

Device Record Status

Public Device Record Key

9e60b878-801c-47e8-aa96-ecbbbd491abd

Public Version Date

January 21, 2020

Public Version Number

1

DI Record Publish Date

January 13, 2020

Additional Identifiers

Package DI Number

50885380170063

Quantity per Package

50

Contains DI Package

10885380170065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40